Turn-Key Solutions for Medical Device Company Needs

For 25 years Rasor Consulting Group has provided clients comprehensive expert coverage of their projects via its unique business model as pictured above. Its Principal, Julia S. Rasor, is a multifunctional expert in the business, clinical/technical, and regulatory arenas and therefore most times provides the sole management and execution of the project. For projects requiring supplementary expertise, Julia builds a customized "A Team" of complementary consultants assembled specifically for the project adding capability in the areas of engineering product development, manufacturing and quality, marketing and sales, reimbursement, and business development. Julia uses her project management and multifunctional skills to centrally integrate this group of experts offering clients turn-key, scalable, best-in-class solutions to their project needs.

Medical Device Strategist and Problem Solver

• Julia S. Rasor is a medical device consultant with both broad and deep business, clinical, and regulatory expertise uniquely able to provide a 'Cross-Functional Big Picture' strategy;
• Integration expert that aligns companies for success by coordinating the business and technical goals;
• Uses unique tools and algorithms developed from a 50-company experience to execute strategy;
• Methods have repeatedly proven effective in putting companies on the 'Fast Track';
  • Solving business, clinical, and regulatory hurdles
  • Identifying and designing around pitfalls
  • Expediting product clearance
  • Optimizing the revenue ramp
  • Obtaining funding
  • Meeting BOD milestones
• Inventor of a $100M/year revenue medical product, first ultrasonic contrast agent;
• Author of 20 White Papers yielding increased sales, venture funding, and FDA acceptance of trial endpoints and reversal of their previously stated decisions;
• Problems Solved for Clients of 100% success with FDA.

Consulting Services

PROJECT BASED CONSULTING:

Business/ Management Turnaround, Troubleshooting Fundraising Assistance, Venture Capital, Angel Opportunity Assessment, Due Diligence Interim Executive Management, CXO Chief Executive Officer (CEO) Chief Science Officer (CSO) Chief Strategy Officer (CSO) Prudent Cash Management Strategy Cross-Functional Big Picture Strategy Entrepreneur, Founder, Start-up CEO Board of Directors (BOD) Business Model Market Research, Product Line-up Customer Research, Surveys Competitor Research Business Development Marketing, Increasing Sales Project Management (PM) Subcontracting/Subcontractor

Clinical/ Technical Scientific Advisory Board (SAB) Clinical Research Organization (CRO) Research and Development (R&D) Intellectual property (IP), Patents Clinical Study Design, Data Analysis Preclinical Study Design, Data Analysis In Vitro Models In Vivo Models Data and Statistics, Bayesian and Frequentist Medical Writing, White Papers, Publications Regulatory IDE, 510(k), PMA submissions Liaison with FDA Responses to FDA Questions Gaining FDA agreement to new regulatory paths Gaining FDA agreement to optimal endpoints

SUBSCRIPTION BASED CONSULTING: Consulting by phone as needed via a renewable subscription where you call anytime for immediate expert advice (choose one of the following options or call to tailor a subscription plan that works best for you): One-year subscription: one hour per month; One-year subscription: four hours per month; Six-month subscription: one hour per month; Six-month subscription: four hours per month.

SUBCONTRACTOR CONSULTING: Inquire about subcontracting, as Rasor Consulting Group occasionally: Subcontracts other consultants with specific expertise e.g., reimbursement, quality, design, manufacturing, and statistics as well as overload assistance in other areas Provides services to other consultants as a subcontractor